21 U.S. Code § 356c–1 - Annual reporting on drug shortages

Not later than the end of calendar year 2013, and not later than the end of each calendar year thereafter, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on drug shortages that—

(1)specifies the number of manufacturers that submitted a notification to the Secretary under section
356c(a) of this title during such calendar year;

(2)describes the communication between the field investigators of the Food and Drug Administration and the staff of the Center for Drug Evaluation and Research’s Office of Compliance and Drug Shortage Program, including the Food and Drug Administration’s procedures for enabling and ensuring such communication;

(3)

(A)lists the major actions taken by the Secretary to prevent or mitigate the drug shortages described in paragraph (7);

(B)in the list under subparagraph (A), includes—

(i)the number of applications and supplements for which the Secretary expedited review under section
356c(g)(1) of this title during such calendar year; and

(ii)the number of establishment inspections or reinspections that the Secretary expedited under section
356c(g)(2) of this title during such calendar year;

(4)describes the coordination between the Food and Drug Administration and the Drug Enforcement Administration on efforts to prevent or alleviate drug shortages;

(5)identifies the number of and describes the instances in which the Food and Drug Administration exercised regulatory flexibility and discretion to prevent or alleviate a drug shortage;

(6)lists the names of manufacturers that were issued letters under section
356c(f) of this title; and

(7)specifies the number of drug shortages occurring during such calendar year, as identified by the Secretary.

(b) Trend analysis

The Secretary is authorized to retain a third party to conduct a study, if the Secretary believes such a study would help clarify the causes, trends, or solutions related to drug shortages.

(c) Definition

In this section, the term “drug shortage” or “shortage” has the meaning given such term in section
356c of this title.